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L'essai clinique NCT05095623 pour Recurrent Bacterial Infection, Autoimmune Disorder est interrompu. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease 3

Interrompu
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L'essai clinique NCT05095623 est une étude observationnel pour Recurrent Bacterial Infection, Autoimmune Disorder. Son statut actuel est : interrompu. L'étude a débuté le 31 août 2021 et vise à recruter 3 participants. Dirigée par Catalyst Biosciences, l'étude devrait être terminée d'ici le 10 février 2022. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 avril 2022.
Résumé succinct
This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.
Description détaillée
This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.

The population will include male and female participants ≥6 months of age (pediatric participants enrolled as permitted by local Institutional Review Board/Independent Ethics Committee). This includes patients with recurrent bacterial infection...

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Titre officiel

A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease

Pathologies
Recurrent Bacterial Infection, Autoimmune Disorder
Autres identifiants de l'étude
  • CFI-002
Numéro NCT
NCT05095623
Date de début (réel)
2021-08-31
Dernière mise à jour publiée
2022-04-08
Date de fin (estimée)
2022-02-10
Inscription (estimée)
3
Type d'étude
Observationnel
Statut
Interrompu
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
N/A
Natural History Observation
This is a natural history study.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
General clinical condition
General clinical condition
Approximately every 3 months
Proportion of patients with episodes or exacerbations of medical events
Proportion of patients with episodes or exacerbations of medical events
Approximately every 3 months
Proportion of patients with infections As applicable, infections (particularly meningococcal and other encapsulated bacteria)
Proportion of patients with infections
Approximately every 3 months
Proportion of patients with kidney disease progression
Proportion of patients with kidney disease progression
Approximately every 3 months
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
6 Months
Sexes éligibles
Tous
  1. Male or female, age 6 months or older
  2. Affirmation of participant's informed consent or legally authorized representative (LAR)'s willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must also be willing to give written informed assent (if able) if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.
  3. Confirmed CFI deficiency during the screening study, CFI-001, with a disease that is associated with an absence or deficiency in CFI
  4. Stated willingness of the participant to comply with all study procedures (including multiple blood draws) and availability for the duration of the study
  5. Stated willingness of the participant (or LAR) to allow access to his/her medical records with the purpose of assessing disease status and progression during his/her participation in the study

  1. Participation in an interventional clinical study within the previous 30 days prior to screening or within ≤5 half-lives of the investigational drug, whichever is longer
  2. Having a major concurrent non-CFI-related disease that prevents the assessment of the natural course of the CFI deficiency disease
  3. Having a medical, psychosocial, or familial issues that might prevent full participation and cooperation with the procedures and requirements of the clinical study as determined by the potential participant/guardian and physician investigator
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1 Centres de l'étude dans 1 pays

Alabama

Nephrology Consultants, LLC, Huntsville, Alabama, 35805, United States